PatellarTape SystemTM
For Patellar Tendon Reconstruction
Surgical Technique Manual
0086
Introduction
PatellarTape SystemTM
The PatellarTape System comprises a wide open weave
Poly-Tape prosthesis, associated instrumentation and
optional Fastlok™ titanium alloy staple to repair a ruptured
patellar tendon, without the need to harvest autogenous
tissue.
We would like to thank Mr A. D. Toms, Consultant
Orthopaedic Surgeon, Royal Devon and Exeter Hospital,
Exeter, UK and Mr S. H. White, Consultant Orthopaedic
Surgeon, Robert Jones and Agnes Hunt Orthopaedic
Hospital, Shropshire, UK, for their work in developing this
technique1.
IMPLANTS
The Poly-Tape recommended for patellar tendon repairs is
the 30 mm wide by 800 mm long prosthesis. It is an open
weave polyester mesh, designed to act as a scaffold for
soft tissue ingrowth and neoligament formation.
Advantages of the Poly-Tape prosthesis:
• it provides excellent intrinsic strength and allows early
mobilization;
• the use of metalwork and wire cerclage is
unnecessary and the associated high complication
rate and problems of secondary removal are thus
avoided;
• the prosthesis carries none of the risks or availability
problems of allograft;
• there is no donor site morbidity as encountered with
autograft;
• it is a simple, easy to learn technique with a low
complication rate.
Various methods can be used to secure the Poly-Tape
which include knotting and stapling. Neoligaments
recommends the Fastlok if stapling is preferred.
The Fastlok is made from a titanium alloy and consists of
a staple and buckle. It provides a unique triple clamping
action to minimize slippage under repeated loading.
INSTRUMENTATION
The following single use instruments are packed with the
implant set:
• 20 cm malleable probe with eye for passing the PolyTape through the soft tissue;
• a 4.5 mm diameter drill bit (plain shank).
If the Fastlok is chosen as the method of fixation, the user
can also order the following standard items:
• Fastlok impactor/extractor;
• Fastlok sliding hammer.
INDICATIONS
The use of the Poly-Tape for
patellar tendon reconstruction
is particularly recommended
for the following types of
cases:
• where the diagnosis of
rupture is delayed;
• ruptures where prolonged
immobilization would be
undesirable;
• patients who have a total
knee arthroplasty in situ;
• cases where a previous
patellectomy has been
performed;
• complex patellar fractures
(although no surgical
technique is described in
this manual).
Contraindications, warnings
and precautions: Please
refer to the general
Contraindications, Warnings
and Precautions listed in the
Poly-Tape and Fastlok
Instructions for Use leaflets
(Ref. LAB 028 and LAB 108)
packed with the implants.
Surgical Technique
1
PREPARATION AND INSPECTION
The patient is positioned supine. Broad spectrum
antibiotic prophylaxis is administered intravenously. A
side support and sandbag are useful to facilitate knee
positioning. The leg is prepared and draped using aseptic
technique.
RECOMMENDED APPROACH
A midline approach is recommended. Adequate exposure
is essential and should provide sufficient access for the
proximal and distal placement of the prosthesis. The ends
of the tendon or ligament are identified as well as any
additional pathology.
NOTE: It is necessary particularly in chronic cases to free
up any adhesions involving the quadriceps mechanism.
This will facilitate optimal post-operative rehabilitation.
A transverse bone tunnel is positioned at the level of the
tibial tuberosity. A 4.5 mm diameter drill bit (as provided
in the system pack) is used to make the tunnel from the
lateral side to the medial.
NOTE: Where possible, round the tunnel edges to prevent
abrasion of the Poly-Tape.
The Poly-Tape is threaded through the eyelet of the probe
(as provided in the system pack). The probe is used
to pass the Poly-Tape transversely through the distal
quadriceps tendon at its patellar insertion.
2
The Poly-Tape is brought distally, crossing over itself on
the anterior aspect of the patella. The medial end of the
Poly-Tape is passed through the bone tunnel. The ends
of the Poly-Tape are pulled tight with the knee in 20º of
flexion.
The position is then secured with stay sutures to allow the
range of motion and tissue tension to be assessed.
Secure
with
knot
Secure
with
knot
3
Both ends of the Poly-Tape are then either secured to the
lateral tibial metaphysis using two bone staples under
cover of the tibialis anterior muscle, or the ends may be
tied in a knot.
NOTE: Alternatively a single 8 mm Fastlok (Neoligaments)
is used for tibial fixation. Please see the Instructions For
Use leaflet (document LAB 108), which is packaged with
the Fastlok for the implantation technique.
NOTE: The protruded profile of the Fastlok may cause
pain or irritation to some recipients and so may need
removal on some such occasions after biological fixation
between the graft and tunnel is achieved.
The range of motion and tissue tension is assessed. If
this is satisfactory each surplus end of the Poly-Tape is
cut with scissors at right angles to its length. This will
minimize the generation of loose fibres. A short tail is left
when cutting each end.
4
IMPORTANT:
• Any loose fibres created when trimming the Poly-Tape
to length must be carefully removed from the incision
site.
• After trimming to length it may be necessary to
restrain the cut ends by stitching them back to the
Poly-Tape.
• Where possible ensure the knot is buried in tissue.
The remnants of the ruptured tendon are sutured over the
Poly-Tape, to encourage fibrous ingrowth and distance the
prosthesis from the superficial wound.
WOUND CLOSURE
The wound is irrigated and a vacuum drain is put in
place. Haemostasis achieved. The dead space is closed
with absorbable sutures before skin closure with a
subcuticular, absorbable suture. The wound is covered
with a dressing followed by a wool and crepe bandage.
5
TECHNIQUE FOR RECONSTRUCTION OF
EXTENSOR MECHANISM RUPTURE POST
PATELLECTOMY
The Poly-Tape is passed transversely through a 4.5 mm
diameter tunnel at the level of the tibial tuberosity.
The Poly-Tape is crossed over the torn extensor
mechanism. It is passed through the remnant of the
quadriceps tendon and muscle. The free ends are
brought out proximally and laterally, knotted and sutured
to the surrounding extensor mechanism.
The patella retinaculum is repaired and the Poly-Tape is
sutured to the fibrous tissue envelope.
POST-OPERATIVE MANAGEMENT
The rehabilitation programme (below) provides
only an outline of the prescribed regime. For a full
description refer to the document entitled “PatellarTape
System Rehabilitation Programme for Patellar Tendon
Reconstruction” (LAB 133).
The rehabilitation programme should be supervised by a
specialist physiotherapist. All mobilization and exercises
should be performed within the pain free range of
movement.
Week 3 to 6
• Balance exercises and proprioceptive training is
commenced.
Week 6 to 12
• Elliptical trainer and functional training are
commenced.
Week 12 onwards
• Jog-walk and jog run exercises are commenced.
•
As in any implant surgery satisfactory wound healing is of
paramount importance.
The patient should be warned not to exceed the
prescribed activity levels or to overload the repair before
complete healing has occurred.
This Rehabilitation Programme was developed in
conjunction with Ian Horsley MSc, MCSP, Clinical Lead
Physiotherapist, English Institute of Sport (EIS) North
West, of BackinAction Physiotherapy and Sports Injury
Clinic, Wakefield, UK.
Week 0 to 1
• The patient may fully weight bear using crutches for
stability (3 point gait moving towards reciprocal gait).
•
A brace or splint is used to allow the patient to
mobilize between physiotherapy sessions.
•
The rehabilitation programme is commenced with
active extension. Do not aggressively push flexion.
Week 1 to 3
• Rehabilitation is continued with increasing repetitions
and static cycling and pool work are commenced.
•
Crutches are discarded when the patient has a
reciprocal gait pattern.
•
The brace is discarded when full terminal knee
extension control is achieved.
•
Sutures are typically removed at this stage.
On agreement with the physiotherapist, return to
activity is allowed.
REFERENCE
1.
Toms AD, Smith A, White SH. Analysis of the
Leeds-Keio ligament for extensor mechanism repair:
favourable mechanical and functional outcome. Knee.
2003;10(2):131-134.
For further references on this procedure please refer to
the document “Neoligaments Scientific Articles” (LAB
144). This may be obtained from the Neoligaments
sales department, or downloaded from http://www.
neoligaments.com/doclib/
Ordering Information
102-1062
PatellarTape System, includes:
30 mm x 800 mm Poly-Tape (supplied sterile)
Packaged with the following disposables:
Probe with eye - nickel silver 20 cm (supplied sterile)
Drill bit, plain shank to fit Jacobs Chuck, 4.5 mm diameter (supplied sterile)
102-1381
Optional Implant (dependent on method of fixation chosen by the user):
8 mm Titanium Fastlok (supplied sterile)
Fastlok Instruments:
202-1137
202-1118
Impactor/Extractor (non-sterile)
Sliding Hammer (non-sterile)
Individual re-order Codes:
102-1083
202-3008
202-3021
30 mm x 800 mm Poly-Tape (supplied sterile)
Probe with eye - nickel silver 20 cm (supplied sterile)
Drill bit, plain shank to fit Jacobs Chuck, 4.5 mm diameter (supplied sterile)
Please refer to the Instructions for Use leaflet packed with the Poly-Tape and Fastlok for essential information including Use, Sterility, Indications, Contraindications, Warnings and Precautions,
Potential Adverse Effects and Storage. Additional copies may be obtained from Neoligaments sales department, or downloaded from http://www.neoligaments.com/doclib/
Developed and manufactured by
Neoligaments™
A division of Xiros™
Springfield House
Whitehouse Lane
Leeds LS19 7UE
Tel. +44 (0) 113 238 7202
Fax. +44 (0) 113 238 7201
[email protected]
www.neoligaments.com
Registered in England No. 1664824.
All rights reserved. © Neoligaments™ 2011.
Worldwide patents and patents pending.
Neoligaments, PatellarTape System, Fastlok and Xiros are
trademarks of Xiros.
LAB 112 3.00